Safety of recombinant human hyaluronidase PH20 for subcutaneous drug delivery

Subcutaneous Injection Performance in Yucatan Miniature Pigs with and without Human Hyaluronidase and Auto-injector Tolerability in Humans

(2021) Galen H. Shi et al.   AAPS PHARMSCITECH

Use of recombinant human hyaluronidase-facilitated subcutaneous immunoglobulin in elderly patients

(2020) Pieter van Paassen et al.   Immunotherapy

Safety and tolerability of subcutaneous trastuzumab at home administration, results of the phase IIIb open-label BELIS study in HER2-positive early breast cancer

(2020) Hannelore Denys et al.   BREAST CANCER RESEARCH AND TREATMENT

Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial

(2020) Maria-Victoria Mateos et al.   Lancet Haematology

A Preclinical Investigation into the Effects of Aging on Dermal Hyaluronan Properties and Reconstitution Following Recombinant Human Hyaluronidase PH20 Administration

(2020) Robert J. Connor et al.   Dermatology and Therapy

Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection plus chemotherapy in HER2-positive early breast cancer (FeDeriCa): a randomised, open-label, multicentre, non-inferiority, phase 3 study

(2020) Antoinette R Tan et al.   LANCET ONCOLOGY

ENHANZE® drug delivery technology: a novel approach to subcutaneous administration using recombinant human hyaluronidase PH20

(2019) Kenneth W. Locke et al.   DRUG DELIVERY

Results From the First Multicenter, Open-label, Phase IIIb Study Investigating the Combination of Pertuzumab With Subcutaneous Trastuzumab and a Taxane in Patients With HER2-positive Metastatic Breast Cancer (SAPPHIRE)

(2019) Natasha Woodward et al.   Clinical Breast Cancer

Subcutaneous vs Intravenous Trastuzumab for Patients With ERBB2-Positive Early Breast Cancer

(2019) Christian Jackisch et al.   JAMA Oncology

Subcutaneous Delivery of Daratumumab in Relapsed or Refractory Multiple Myeloma

(2019) Saad Z. Usmani et al.   BLOOD

Safety of switching from intravenous to subcutaneous rituximab during first‐line treatment of patients with non‐Hodgkin lymphoma: the Spanish population of the MabRella study

(2019) Ricardo García‐Muñoz et al.   BRITISH JOURNAL OF HAEMATOLOGY

Recombinant Human PH20: Baseline Analysis of the Reactive Antibody Prevalence in the General Population Using Healthy Subjects

(2018) Sanna Rosengren et al.   BIODRUGS

Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities

(2018) Beate Bittner et al.   BIODRUGS

Safety profile of subcutaneous trastuzumab for the treatment of patients with HER2-positive early or locally advanced breast cancer: primary analysis of the SCHEARLY study

(2018) Milvia Zambetti et al.   EUROPEAN JOURNAL OF CANCER

Development of a Subcutaneous Fixed-Dose Combination of Pertuzumab and Trastuzumab: Results From the Phase Ib Dose-Finding Study

(2018) Whitney P. Kirschbrown et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer: SafeHer phase III study's primary analysis of 2573 patients

(2017) J. Gligorov et al.   EUROPEAN JOURNAL OF CANCER

Efficacy and safety of subcutaneous and intravenous rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone in first-line diffuse large B-cell lymphoma: the randomized MabEase study

(2017) Pieternella Lugtenburg et al.   HAEMATOLOGICA

Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab

(2017) Paul M Ridker et al.   NEW ENGLAND JOURNAL OF MEDICINE

Efficacy and safety of subcutaneous and intravenous rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone in first-line diffuse large B-cell lymphoma: the randomized MabEase study

(2017) Pieternella Lugtenburg et al.   HAEMATOLOGICA

Efficacy and safety of subcutaneous rituximab versus intravenous rituximab for first-line treatment of follicular lymphoma (SABRINA): a randomised, open-label, phase 3 trial

(2017) Andrew Davies et al.   Lancet Haematology

Subcutaneous administration of human C1 inhibitor with recombinant human hyaluronidase in patients with hereditary angioedema

(2016) Marc A. Riedl et al.   ALLERGY AND ASTHMA PROCEEDINGS

Preference for subcutaneous or intravenous administration of rituximab among patients with untreated CD20+ diffuse large B-cell lymphoma or follicular lymphoma: results from a prospective, randomized, open-label, crossover study (PrefMab)

(2016) M. Rummel et al.   ANNALS OF ONCOLOGY

Recombinant human hyaluronidase facilitated subcutaneous immunoglobulin treatment in pediatric patients with primary immunodeficiencies: long-term efficacy, safety and tolerability

(2016) Richard L Wasserman et al.   Immunotherapy

Long-Term Tolerability, Safety, and Efficacy of Recombinant Human Hyaluronidase-Facilitated Subcutaneous Infusion of Human Immunoglobulin for Primary Immunodeficiency

(2016) Richard L. Wasserman et al.   JOURNAL OF CLINICAL IMMUNOLOGY

A time and motion study of subcutaneous versus intravenous trastuzumab in patients with HER2-positive early breast cancer

(2016) Erwin De Cock et al.   Cancer Medicine

Time Savings with Rituximab Subcutaneous Injection versus Rituximab Intravenous Infusion: A Time and Motion Study in Eight Countries

(2016) Erwin De Cock et al.   PLoS One

Clinical Immunogenicity of rHuPH20, a Hyaluronidase Enabling Subcutaneous Drug Administration

(2015) Sanna Rosengren et al.   AAPS Journal

The Content and Size of Hyaluronan in Biological Fluids and Tissues

(2015) Mary K. Cowman et al.   Frontiers in Immunology

Subcutaneous versus intravenous formulation of trastuzumab for HER2-positive early breast cancer: updated results from the phase III HannaH study

(2014) C. Jackisch et al.   ANNALS OF ONCOLOGY

Tolerability and Pharmacokinetic Properties of Ondansetron Administered Subcutaneously With Recombinant Human Hyaluronidase in Minipigs and Healthy Volunteers

(2014) Samuel S. Dychter et al.   CLINICAL THERAPEUTICS

Overview of recombinant human hyaluronidase-facilitated subcutaneous infusion of IgG in primary immunodeficiencies

(2014) Richard L Wasserman   Immunotherapy

Hyaluronan: A simple polysaccharide with diverse biological functions

(2013) Kevin T. Dicker et al.   Acta Biomaterialia

Pharmacokinetics and pharmacodynamics of single subcutaneous doses of tocilizumab administered with or without rHuPH20

(2013) Peter N. Morcos et al.   INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS

Preference for subcutaneous or intravenous administration of trastuzumab in patients with HER2-positive early breast cancer (PrefHer): an open-label randomised study

(2013) Xavier Pivot et al.   LANCET ONCOLOGY

Metabolic control of hyaluronan synthases

(2013) Davide Vigetti et al.   MATRIX BIOLOGY

Mechanistic Determinants of Biotherapeutics Absorption Following SC Administration

(2012) Wolfgang F. Richter et al.   AAPS Journal

A Randomized Clinical Trial of Recombinant Human Hyaluronidase-Facilitated Subcutaneous Versus Intravenous Rehydration in Mild to Moderately Dehydrated Children in the Emergency Department

(2012) Philip R. Spandorfer et al.   CLINICAL THERAPEUTICS

Comparative Pharmacokinetics and Insulin Action for Three Rapid-Acting Insulin Analogs Injected Subcutaneously With and Without Hyaluronidase

(2012) L. Morrow et al.   DIABETES CARE

Recombinant human hyaluronidase-facilitated subcutaneous infusion of human immunoglobulins for primary immunodeficiency

(2012) Richard L. Wasserman et al.   JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

Progress in Gammaglobulin Therapy for Immunodeficiency: From Subcutaneous to Intravenous Infusions and Back Again

(2012) Richard L. Wasserman   JOURNAL OF CLINICAL IMMUNOLOGY

Comparison of Subcutaneous and Intravenous Administration of Trastuzumab: A Phase I/Ib Trial in Healthy Male Volunteers and Patients With HER2-Positive Breast Cancer

(2012) Chris Wynne et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I–III breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised trial

(2012) Gustavo Ismael et al.   LANCET ONCOLOGY

Reduction in Intrasubject Variability in the Pharmacokinetic Response to Insulin After Subcutaneous Co-Administration with Recombinant Human Hyaluronidase in Healthy Volunteers

(2011) Linda Morrow et al.   Diabetes Technology & Therapeutics

Use of Recombinant Human Hyaluronidase to Accelerate Rapid Insulin Analogue Absorption: Experience with Subcutaneous Injection and Continuous Infusion

(2011) Daniel Vaughn et al.   Endocrine Practice

A comprehensive model of hyaluronan turnover in the mouse

(2011) Laurence Jadin et al.   MATRIX BIOLOGY

Comparison of the tolerability of recombinant human hyaluronidase + normal saline and recombinant human hyaluronidase + lactated ringer's solution administered subcutaneously: A phase IV, double-blind, randomized pilot study in healthy volunteers

(2010) Samuel S. Dychter et al.   CURRENT THERAPEUTIC RESEARCH-CLINICAL AND EXPERIMENTAL

Safety and pharmacokinetics of subcutaneous ceftriaxone administered with or without recombinant human hyaluronidase (rHuPH20) versus intravenous ceftriaxone administration in adult volunteers

(2009) George Harb et al.   CURRENT MEDICAL RESEARCH AND OPINION

Accelerated Pharmacokinetics and Glucodynamics of Prandial Insulins Injected With Recombinant Human Hyaluronidase

(2009) Daniel E. Vaughn et al.   Diabetes Technology & Therapeutics

The INFUSE-Morphine IIB Study: Use of Recombinant Human Hyaluronidase (rHuPH20) to Enhance the Absorption of Subcutaneous Morphine in Healthy Volunteers

(2009) Jay R. Thomas et al.   JOURNAL OF PAIN AND SYMPTOM MANAGEMENT

The INFUSE-Morphine Study: Use of Recombinant Human Hyaluronidase (rHuPH20) to Enhance the Absorption of Subcutaneously Administered Morphine in Patients with Advanced Illness

(2009) Jay R. Thomas et al.   JOURNAL OF PAIN AND SYMPTOM MANAGEMENT

Recombinant Human Hyaluronidase-Enabled Subcutaneous Pediatric Rehydration

(2009) C. H. Allen et al.   PEDIATRICS